b-ONE Hip Instrumentation - Offset Rasp - B-ONE ORTHO, CORP.

Duns Number:081315444

Device Description: Offset Rasp

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More Product Details

Catalog Number

8819065000

Brand Name

b-ONE Hip Instrumentation

Version/Model Number

8819065000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

eb755466-a069-42f4-add1-1f3f7e2c7d82

Public Version Date

September 23, 2020

Public Version Number

1

DI Record Publish Date

September 15, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"B-ONE ORTHO, CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 273
2 A medical device with a moderate to high risk that requires special controls. 707